The Effect of Frailty on Blood Biology Indicators, Quality of Life and Survival of Patients With Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Change of Quality of Life from baseline(Quality of Life is a generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease.)
研究概览
简要总结
The goal of this observational study is to evaluate the effect of frailty on blood biology indicators, quality of life and survival of patients with radical prostatectomy.
The main questions it aims to answer are:
- Evaluate the impact of frailty on the blood biological indicators, quality of life and survival of patients with radical prostatectomy, specifically.
- Describe the longitudinal changes in the quality of life of patients with radical prostatectomy.
Participants will be divided into frail group or non-frail group based on frailty assessment. Researchers will compare the two groups to see the impact of frailty on the blood biological indicators, quality of life and survival.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with prostate cancer (be diagnosed by relevant imaging examinations or pathology);
- •Radical prostatectomy is planned;
- •Voluntarily sign the informed consent form.
排除标准
- •Diagnosed with other malignant tumors at the same time;
- •Patients with acute infection.
结局指标
主要结局
Change of Quality of Life from baseline(Quality of Life is a generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral, social environment as well as health and disease.)
时间窗: baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.
Quality of life will be measured by the Extended Prostate Cancer Composite Index Scale (EPIC-26). EPIC-26 is used to assess the functional status of patients with prostate cancer in various domains over the past 4 weeks. Be si de s, EPIC-26 is used to describe the extent of its affects in life of patients with prostate cancer. EPIC-26 contains 26 items in five areas, including urinary incontinence, urinary tract irritation, defecation function, sexual function, and endocrine disorders. Cronbach α coefficient of the scale was 0.854. The overall score is 100 points, and the lower score means better quality of life.
次要结局
- Blood Biology Indicators(including IL-2, IL-6, IL-8,TNF-α, PSA and et al)(baseline(date of hospitalization); 1 month after operation; 3 months after operation; 6 months after operation; 1 year after operation; 2 years after operation.)